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NATtrol™

FDA UDI

Class I (US FDA UDI)

by ZeptoMetrix LLC

Identity

Trade Name
NATtrol™ FDA UDI
Generic Name
Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
Device Name
The NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. FDA UDI
Model / Reference
NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control FDA UDI
Description
The NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. FDA UDI

Identifiers

Catalog Number
NATFRC-6C-IVD FDA UDI
Primary DI / UDI-DI
01220000260337 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus respiratory virus nucleic acid IVD, control

NATtrol™ by ZeptoMetrix LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZeptoMetrix LLC

Sources (1)

  • FDA UDI 371fff6f-bd7c-4d9d-b10a-4b4942168d4a 36 fields · synced May 30, 2026